CompletedNot Applicable

Assessment of Safety and Feasibility of ExAblate Blood-Brain Barrier (BBB) Disruption in GBM Patients

Italy, Spain3 participantsStarted 2021-08-25

Plain-language summary

The purpose of this study is to evaluate the safety of the Exablate Model 4000 Type 2.0 used as a tool to disrupt the BBB in patients with high grade glioma undergoing standard of care therapy.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Patient is eligible for adjuvant TMZ treatment.
. Men or women age between 18 and 80 years, inclusive.
. Able and willing to give informed consent.
. Grade IV glioma (GBM) confirmed Subjects
. Karnofsky rating 70-100.
. Able to communicate during the Exablate BBBD procedure.
. Life expectancy of at least 3 months.

Exclusion criteria

. Evidence of acute intracranial hemorrhage.
. The subject presents with severe symptoms and signs of increased intracranial pressure
. Patients with cerebellar or brainstem tumors.
. Patients with positive HIV status
. Patients with brain tumors containing 1p/19q chromosomal co-deletion

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Device and procedure related adverse events

Timeframe: Throughout the study, approximately 12 months.

Feasibility of repeated BBB disruption will be evaluated through assessment of post-procedure contrast-enhanced magnetic resonance (MR) imaging

Timeframe: At the time of each ExAblate MRgFUS procedure]

Trial details

NCT IDNCT04998864

SponsorInSightec

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2023-07-27

View on ClinicalTrials.gov More Glioma, Malignant trials